McRackan Theodore R, Velozo Craig A, Holcomb Meredith A, Camposeo Elizabeth L, Hatch Jonathan L, Meyer Ted A, Lambert Paul R, Melvin Cathy L, Dubno Judy R
Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston.
Division of Occupational Therapy, Medical University of South Carolina, Charleston.
JAMA Otolaryngol Head Neck Surg. 2017 Oct 1;143(10):975-982. doi: 10.1001/jamaoto.2017.1182.
No instrument exists to assess quality of life (QOL) in adult cochlear implant (CI) users that has been developed and validated using accepted scientific standards.
To develop a CI-specific QOL instrument for adults in accordance with the Patient Reported Outcomes Measurement Information System (PROMIS) guidelines.
DESIGN, SETTING, AND PARTICIPANTS: As required in the PROMIS guidelines, patient focus groups participated in creation of the initial item bank. Twenty-three adult CI users were divided into 1 of 3 focus groups stratified by word recognition ability. Three moderator-led focus groups were conducted based on grounded theory on December 3, 2016. Two reviewers independently analyzed focus group recordings and transcripts, with a third reviewer available to resolve discrepancies. All data were reviewed and reported according to the Consolidated Criteria for Reporting Qualitative Research. The setting was a tertiary referral center.
Coded focus group data.
The 23 focus group participants (10 [43%] female; mean [range] age, 68.1 [46.2-84.2] years) represented a wide range of income levels, education levels, listening modalities, CI device manufacturers, duration of CI use, and age at implantation. Data saturation was determined to be reached before the conclusion of each of the focus groups. After analysis of the transcripts, the central themes identified were communication, emotion, environmental sounds, independence and work function, listening effort, social isolation and ability to socialize, and sound clarity. Cognitive interviews were carried out on 20 adult CI patients who did not participate in the focus groups to ensure item clarity. Based on these results, the initial QOL item bank and prototype were developed.
Patient focus groups drawn from the target population are the preferred method of identifying content areas and domains for developing the item bank for a CI-specific QOL instrument. Compared with previously used methods, the use of patient-centered item development for a CI-specific QOL instrument will more accurately reflect patient experience and increase our understanding of how CI use affects QOL.
目前尚不存在一种按照公认科学标准开发并验证的用于评估成人人工耳蜗（CI）使用者生活质量（QOL）的工具。
根据患者报告结局测量信息系统（PROMIS）指南，为成人开发一种特定于人工耳蜗的生活质量工具。
设计、背景和参与者：按照PROMIS指南的要求，患者焦点小组参与了初始项目库的创建。23名成年人工耳蜗使用者按单词识别能力分为3个焦点小组中的1个。2016年12月3日，基于扎根理论进行了3次由主持人引导的焦点小组讨论。两名评审员独立分析焦点小组的录音和文字记录，第三名评审员负责解决分歧。所有数据均根据定性研究报告的综合标准进行审查和报告。研究地点为三级转诊中心。
编码后的焦点小组数据。
23名焦点小组参与者（10名[43%]女性；平均[范围]年龄为68.1[46.2 - 84.2]岁）代表了广泛的收入水平、教育水平、听力方式、人工耳蜗设备制造商、人工耳蜗使用时长以及植入时的年龄。在每个焦点小组结束前确定已达到数据饱和。对文字记录进行分析后，确定的核心主题包括沟通、情绪、环境声音、独立性和工作功能、听力努力、社会隔离与社交能力以及声音清晰度。对20名未参与焦点小组的成年人工耳蜗患者进行了认知访谈，以确保项目清晰易懂。基于这些结果，开发了初始生活质量项目库和原型。
从目标人群中抽取的患者焦点小组是确定特定于人工耳蜗的生活质量工具项目库内容领域和范畴的首选方法。与先前使用的方法相比，针对特定于人工耳蜗的生活质量工具采用以患者为中心的项目开发将更准确地反映患者体验，并增进我们对人工耳蜗使用如何影响生活质量的理解。
